Infectious Diseases News Alerts

• Alert FDA OKs New Antibacterial Cefiderocol for Complicated UTI Last month, an FDA panel recommended approval of cefiderocol for treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by Gram-negative bacteria.
  FDA Approvals, November 15, 2019
• Alert FDA Clears Next-Gen Assay to Detect HIV-1 Drug Resistance The Sentosa SQ HIV genotyping assay is the first HIV drug resistance assay that uses next generation sequencing technology that the FDA has authorized for use.
  FDA Approvals, November 06, 2019
• Alert FDA OKs Fluzone High-Dose Influenza Vaccine for Older Adults Sanofi will transition completely from the trivalent to quadrivalent Fluzone high-dose influenza vaccines in the US. The quadrivalent vaccine will be available for the 2020-2021 flu season.
  FDA Approvals, November 05, 2019
• Alert FDA OKs First Rifabutin-Based H pylori Therapy Talicia Talicia combines omeprazole, amoxicillin, and rifabutin and is designed to address growing bacterial resistance to standard clarithromycin-based H pylori therapy.
  FDA Approvals, November 04, 2019
• Alert EMA Updates Advice on Risk of Blood Clots With Tofacitinib The EMA safety committee says tofacitinib should be used with caution in all patients at high risk for blood clots.
  News Alerts, October 31, 2019
• Alert FDA Approves New Indication for Delafloxacin for CABP Following approval in 2017 for bacteria skin infections, the fluoroquinolone antibiotic is now indicated for adults with community-acquired bacterial pneumonia.
  FDA Approvals, October 25, 2019
• Alert EU Committee Backs Delafloxacin for ABSSSI A European Medicines Agency advisory panel recommended delafloxacin for acute bacterial skin and skin structure infections in adults when other commonly used antibacterial drugs are inappropriate.
  International Approvals, October 18, 2019
• Alert EU Panel Gives Thumbs-Up on First Ebola Vaccine The V920 Ebola Zaire vaccine (Ervebo, Merck) protects against Ebola virus disease caused by Zaire Ebola virus in at-risk adults aged 18 years or older.
  International Approvals, October 18, 2019
• Alert FDA Allows Marketing of First Rapid Ebola Test The FDA has allowed marketing of the first rapid diagnostic test (RDT) to identify Ebola virus antigens, or proteins, in certain body fluids from living and deceased individuals.
  FDA Approvals, October 10, 2019
• Alert FDA Further Expands Approval of HCV Combo Drug Mavyret Mavyret is the first 8-week treatment approved for all treatment-naive adult and certain pediatric patients with any hepatitis C virus genotype, both without cirrhosis and with compensated cirrhosis.
  FDA Approvals, September 26, 2019
• Alert FDA Approves Vaccine Against Smallpox, Monkeypox The approval is in part intended to protect against the potentially devastating consequences of intentional release of the smallpox virus, and the vaccine will be included in the Strategic National Stockpile.
  FDA Approvals, September 24, 2019
• Alert FDA Expands Indications for Pifeltro and Delstrigo for HIV The FDA expanded the indications for the two HIV drugs to include appropriate patients with HIV-1 with virological suppression.
  FDA Approvals, September 20, 2019
• Alert Gavi Vaccine Alliance Wins 2019 Lasker Public Service Award The Vaccine Alliance is being honored for providing sustained access to childhood vaccines around the globe, saving millions of lives and highlighting the power of immunization to prevent disease.
  Medscape Medical News, September 10, 2019
• Alert FDA Urges Transition to Disposable Duodenoscopes The FDA wants to move away from using duodenoscopes with fixed endcaps to those with disposable components or to fully disposable duodenoscopes when they become available.
  News Alerts, August 29, 2019
• Alert Serious Liver Injury Tied to HCV Drugs in Rare Cases, FDA Warns The US Food and Drug Agency has warned that three direct-acting antiviral drugs have been associated with rare cases of severe liver injury in patients being treated for hepatitis C virus infection.
  News Alerts, August 29, 2019
• Alert FDA OKs First-in-Class Antibiotic Lefamulin (Xenleta) for CABP The new semisynthetic pleuromutilin antibiotic will be available for oral and IV administration with a short 5- to 7-day course of therapy for community-acquired bacterial pneumonia (CABP).
  FDA Approvals, August 19, 2019
• Alert FDA OKs 'Game Changer' Pretomanid for Highly Resistant TB Pretomanid is only the third approved TB drug in 40 years. A pivotal study shows the oral drug regimen has a success rate of 89% and treatment takes 6 months instead of the current 2 years.
  FDA Approvals, August 14, 2019
• Alert FDA OKs Streamlined Lyme Disease Tests to Aid Earlier Diagnosis The modified approach for detecting exposure to Borrelia burgdorferi uses two enzyme immunoassays, with no need for Western blot.
  FDA Approvals, July 30, 2019
• Alert EMA Panel Recommends Ibalizumab for Multidrug-Resistant HIV-1 A European Medicines Agency advisory panel recommended marketing authorization for ibalizumab (Trogarzo, Theratechnologies International) for the treatment of patients with multidrug-resistant HIV-1 infection.
  International Approvals, July 29, 2019
• Alert FDA Approves Drug Trio for UTI, Intra-abdominal Infection The FDA approved the antibacterial drug trio imipenem, cilastatin, and relebactam for adults with complicated urinary tract infections and complicated intra-abdominal infections.
  FDA Approvals, July 17, 2019